Interchangeable mask assembly

ABSTRACT

A system of breathing arrangements for delivering breathable gas to a patient includes at least first and second cushion components, e.g., full-face, nasal, nasal prongs, nose tip, and/or a combination of any of the above, including a nasal or full-face cushion and nasal prongs/nozzles combination, etc., that are different from one another in at least one aspect, and a common frame assembly configured to support each of the first and second cushion components. Various embodiments are directed to a full-face or nasal mask used with a frame having lateral connector portions having a stiffening member. The mask assembly may include a nose height adjustment device for the height of the cushion, or a cushion adjustment member by which the position of the cushion may be adjusted relative to the frame. The mask assembly may include a chin strap assembly.

CROSS REFERENCE TO APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/841,488, filed Dec. 14, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/289,158, filed May 28, 2014, now U.S. Pat. No.9,962,510, which is a continuation of U.S. patent application Ser. No.12/083,779, filed Jan. 6, 2009, which is the U.S. national phase ofInternational Application No. PCT/AU2006/001570, filed Oct. 24, 2006which designated the U.S. and claims the benefit of U.S. ProvisionalApplication No. 60/729,746, filed Oct. 25, 2005, each of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a nasal assembly used for treatment,e.g., of Sleep Disordered Breathing (SDB) with Continuous PositiveAirway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation(NPPV).

BACKGROUND OF THE INVENTION

Interfaces, such as a nasal mask assembly, for use with blowers and flowgenerators in the treatment of sleep disordered breathing (SDB)typically include a soft-face contacting portion, such as a cushion, anda rigid shell or frame. In use, the interface is held in a sealingposition by headgear so as to enable a supply of air at positivepressure (e.g. 2-30 cm H₂O) to be delivered to the user's or patient'sor user's airways.

One factor in the efficacy of therapy and compliance of patients withtherapy is the comfort and fit of the patient interface. It has beennecessary to design a wide variety of masks to best treat and/or suitthe user's needs. While there are a large number of patient interfaces,typically each cushion has been specially designed to be used with onlya single frame, headgear, etc.

Puritan Bennett includes a mask commercially sold under the name ofBreeze® that allows a cushion sold under the name of DreamSeal® to beretrofit to it. Further details of such mask are disclosed at thewebsite http://www.puritanbennett.com/prod/Product.aspx?S1=SPT&S2=&id=233.

BRIEF SUMMARY OF THE INVENTION

One aspect of the present invention is to provide a mask assemblyincluding at least one main component that can be used with a variety ofdifferent styles or types of mask assemblies.

In one embodiment of the invention, there is provided a system ofbreathing arrangements for delivering breathable gas to a patient,comprising at least first and second cushion components that aredifferent from one another in at least one aspect, and a common frameassembly configured to support each of the first and second cushioncomponents.

In another embodiment of the invention, there is provided a maskassembly for a user comprising a frame having a main body and lateralconnector portions; and a cushion component provided to the frame anddefining a breathing cavity configured to accommodate at least a portionof the user's nose in use, said cushion component including a facecontacting seal portion adapted to sealingly engage with at least aportion of the user's nose in use, said cushion component having anaperture to communicate pressurized gas from the breathing chamber tothe user's airways in use, and a main wall portion, opposite from theaperture, extending upwardly away from the frame, said main wall portionincluding a stiffening portion.

In another embodiment of the invention, there is provided a maskassembly for a user comprising a frame having a main body and lateralconnector portions; and a cushion component provided to the frame anddefining a breathing cavity configured to accommodate at least a portionof the user's nose in use, said cushion component including a facecontacting seal portion adapted to sealingly engage with at least aportion of the user's nose in use, said cushion component having anaperture to communicate pressurized gas from the breathing chamber tothe user's airways in use, and a main wall portion, opposite from theaperture, extending upwardly away from the frame, said frame beingconfigured for positioning beneath the nose and between the user's upperlip and nose in use.

In another embodiment of the invention, a mask assembly for a usercomprising a frame having a main body and lateral connector portions; acushion component provided to the frame and defining a breathing cavityconfigured to accommodate at least a portion of the user's nose in use,said cushion component including a face contacting seal portion adaptedto sealingly engage with at least a portion of the user's nose in use,said cushion component having an aperture to communicate pressurized gasfrom the breathing chamber to the user's airways in use, and a main wallportion, opposite from the aperture, extending upwardly away from theframe, said cushion having an upper portion and a lower portion, whereinat least the upper portion includes a nose height adjusting member.

In another embodiment of the invention, there is provided a maskassembly for a user comprising a frame; a cushion component provided tothe frame and defining a breathing cavity configured to accommodate atleast a portion of the user's nose in use, said cushion componentincluding a face contacting seal portion adapted to sealingly engagewith at least a portion of the user's nose in use, said cushioncomponent having an aperture to communicate pressurized gas from thebreathing chamber to the user's airways in use, and a main wall portion,opposite from the aperture, extending upwardly away from the frame; anda frame adjustment member to adjust the position of the cushioncomponent relative to the frame.

In another embodiment of the invention, there is provided a maskassembly for a user comprising a frame; a cushion component provided tothe frame and defining a breathing cavity configured to accommodate atleast a portion of the user's nose in use, said cushion componentincluding a face contacting seal portion adapted to sealingly engagewith at least a portion of the user's nose in use, said cushioncomponent having an aperture to communicate pressurized gas from thebreathing chamber to the user's airways in use and a main wall portion,opposite from the aperture, extending upwardly away from the frame; anda chin strap assembly including an extension member provided to eachside of the frame and a chin strap having a main chin support portionand straps coupled to the extension members.

In another embodiment of the invention, there is provided a maskassembly for a user comprising a common frame; a cushion componentprovided to the frame and including a pair of nasal prongs or nozzlesadapted to engage the user's nares in use; and a supplemental cushioncomponent in the form of a nasal cushion or a full-face cushion, whereinthe cushion component and the supplemental cushion componentcooperatively seal with the user's face in use.

These and other aspects of the invention will be described in orapparent from the following detailed description of embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described in relation tothe following figures, in which:

FIG. 1 is a schematic view of a mask assembly according to an embodimentof the present invention;

FIGS. 2-13 are views of a mask assembly according to another embodimentof the present invention;

FIG. 14 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIGS. 15-16 are views of a mask assembly according to yet anotherembodiment of the present invention;

FIGS. 17-19 are views of a portion of a mask assembly according to stillanother embodiment of the present invention;

FIG. 20 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIG. 21 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIG. 22 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIG. 23 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIG. 24 is a perspective view of a mask assembly according to anotherembodiment of the present invention;

FIGS. 25-26 are views of a mask assembly according to another embodimentof the present invention; and

FIGS. 27-31 are views of a mask assembly according to still anotherembodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and/or features. It is understoodthat one or more features of any one embodiment may be combinable withone or more features of the other embodiments which combinations formadditional embodiments.

1.0 First Embodiment—Common Frame with Activa™ or UltraMirage™ CushionComponent

FIG. 1 illustrates an interchangeable mask system 5 according to anembodiment of the present invention. Mask system includes a common framecomponent 10, one of two cushion components 15, 20, one of two elbowcomponents 25, 30, and headgear 35. The mask system is intended for usein positive pressure therapy for users with obstructive sleep apnea(OSA) or another respiratory disorder.

The common frame 10 has a main body 40 defining a central opening 45.Main body 40 includes at least two lateral arms 50, each of which can becoupled to a headgear strap 55 of headgear. The straps may be connectedto the frame using a press-fit connector 60, as is known in the art.Common frame 10 may also include a forehead support 65 that has a bridge70 provided with forehead pads 75 to rest against the user's forehead inuse. Forehead support may be adjustably mounted to the common frame, ina manner known in the art.

Common frame 10 is configured to be selectively coupled to one ofcushion components 15, 20 and to one of elbow components 25, 30. Cushioncomponents 15, 20 differ in at least one respect such that one may bemore optimal or preferable for use with one user, while another may bemore suitable or preferably for use with another user. For example,cushion component 15 may be an Activa™ component, while cushioncomponent 20 may be an UltraMirage™ Series II cushion component, bothavailable from ResMed. These cushion components can be significantlydifferent from one another, e.g., the Activa™ includes a gusset portion80 and a cushion clip assembly (not shown) which is not incorporated inthe UltraMirage™ cushion design.

Common frame 10 is also configured for use with either elbow component25, or elbow component 30. Elbow components differ in at least onerespect, e.g., each may include gas washout vents that are configuredfor predetermined washout rates, noise, etc.

Common frame 10 is advantageous since it works with a plurality ofdifferent cushion components, elbow components, forehead supports, etc.,thereby eliminating the need to specifically make the frame for aparticular peripheral component, as is the standard.

2.0 Second Embodiment—Common SWIFT™ Frame with VISTA™ CushionComponent—Below the Nose

FIGS. 2-13 show a mask system 90 according to another embodiment of thepresent invention. As shown in FIG. 2, mask system 90 includes a commonframe 95, a cushion component 100 and a common headgear assembly 105.

Common frame is similar to ResMed's SWIFT™ frame, described in moredetail in relation to U.S. patent application Ser. No. 10/781,929, filedFeb. 20, 2004, incorporated herein by reference in its entirety. Asshown in FIG. 3, common frame includes a main body 110 including twolateral connectors 115. Each lateral connector 115 is provided with aseal portion 120 (FIG. 4). Each seal portion 120 has a channel 125structured to receive and support a ring shaped portion 130 of a yoke135 of the headgear assembly 105. Each seal portion 120 also includes anaperture 140 to receive either an elbow 145 or a plug 150. In analternative, each seal portion 120 may receive an elbow 145, i.e.,receive two sources of gas (without the plug).

FIG. 3 is an exploded view of cushion component 100, frame 95 and a clipelement 175, together defining a cushion sub-assembly 155. FIG. 4 showsthe cushion sub-assembly 155 in the assembled condition, along with yoke135, seal portion 120 and elbow 145. FIG. 5 is a cross sectional view ofthe assembly. FIGS. 6-10 are additional views of the cushion assembly asassembled with lateral headgear straps and associated yokes.

Cushion component 100 includes lateral sides 160 configured to engagewith corresponding channels 165 formed in the frame 95. Cushioncomponent 100 includes an aperture 196 (schematically illustrated) toreceive the user's nose. End portions 170 of cushion component 100 arewrapped around frame 95, and clip element 175 is attached to thesub-assembly of the cushion component and the frame, by sliding the clipelement over the combined cushion component and frame. FIGS. 4 and 13are a cross-sectional view showing the sandwich-like connection betweenthe lateral sides of the cushion 170, the frame 95 and the clip element175.

FIG. 11 is a top view of the mask assembly in use on a user's head,while FIG. 12 is a front view. As seen, common frame 95 is positionedjust below and partially under the user's nose, and above the upper lipof the user. This positioning of the frame to cushion interface closerto the centroid of the mask assembly, which helps keep a low profile(non-obstructive) and reduces moments imposed on the mask assemblytending to pull the mask assembly away from the user's face.

In the embodiment described above, the cushion component 100 is bisected(see FIGS. 4 and 13) along the longitudinal axis of the frame to createlater sides that wrap around the frame for insertion of the channel. Inanother embodiment, the cushion is not necessarily bisected. Instead,the apertures 162 in the lateral sides of the cushion are simplystretched over the connectors of the frame until a protruding portion ofthe cushion engages the respective channels of the frame.

Further, cushion component 100 has an upper portion 200 that isconfigured to contact the transition between the bony and cartilageportions of the user's nose. Generally, with regard to its footprint,the cushion component is similar to ResMed's VISTA™ cushion, asdescribed in U.S. patent application Ser. No. 11/124,251, filed May 9,2005, incorporated herein by reference.

Cushion component 100 has a thickened portion 205 that acts as a pseudoor “soft” frame to provide support for the rest of the membrane of thecushion. Effectively, the thickened portion 205 of the cushion enlargesthe “frame” area of the common Swift™ frame. In this example, thethickened portion 205 has the shape of a semi-circle or trapezoid. See,e.g., FIGS. 2 and 12.

Common headgear assembly 105 is similar to the headgear assemblydescribed in relation to ResMed's U.S. patent application Ser. No.10/781,929. However, common headgear 105 has some differences. Forexample, as shown in FIG. 13, the vectors of the headgear straps 210 arechanged.

In FIGS. 6-13, the elbow 145 is omitted for clarity, although the plug150 is illustrated. As shown in FIGS. 3, 7-8, and 11, the mask assemblyincludes a gas washout vent 215. The vent 215 could be on the frameand/or the cushion component. As shown in FIG. 8, the yoke 130 includesan alignment indicator 220 that aligns with one of a corresponding arrayof indicators 225 on the cushion/frame subassembly. The cushion/framesubassembly is rotatable relative to the headgear to ensure proper fit.

3.0 Third Embodiment—Common Swift™ Frame with Mirage™ Cushion Component

FIG. 14 illustrates a mask assembly 230 include a common frame 235, aheadgear assembly 240 and a cushion component 245. This embodiment issimilar to the prior embodiment, especially as the common frame is thesame as described above in relation to FIGS. 2-13. The main differenceis that the cushion component 245 takes the form of a nasal mask, e.g.,ResMed's Mirage™ type cushion, as described in U.S. Pat. No. 6,112,746,incorporated herein by reference in its entirety. In this embodiment,the cushion component 245 is configured to form a breathing cavity thatsurrounds the nose of the user. The cushion component includes an upperapex portion 250 that makes contact with the bridge of the user's nose,between the eyes.

The cushion component 250 may include a thickened section 255 in orderto help prevent flopping of the cushion away from the user's face. Thethickened section 255 may include a cutout 260 in each corner to reduceforce on the nasal bridge region.

4.0 Fourth Embodiment—Common Swift™ Frame with Vista™ CushionComponent—Over the Nose

FIGS. 15-16 show a mask assembly 275 according to another embodiment ofthe present invention. Mask assembly 275 includes a common frame 280, aheadgear assembly 285, and a cushion component 290 like that describedin relation to FIGS. 2-13 above. One difference in the presentembodiment is the positioning of the common frame 280 relative to theuser's face/nose. Specifically, the common frame 280 is positioned abovethe lower portion of the user's nose, such that the tip of the noseextends below the clip element 295. Further, as shown in FIG. 16, thevectors formed by the headgear straps 300 are slightly different than asshown in described in relation to FIG. 13. As a result of thepositioning of the frame/cushion interface to more centrally locate theframe relative to the cushion, and/or because the vectors from theheadgear straps act closer to the centroid of the mask on the face, thisdesign may not necessarily include a thickened portion of the cushion.

5.0 Fifth Embodiment—Vista/Swift Prongs Combination

FIGS. 17-19 show a portion of another mask assembly 305 according to anembodiment of the present invention. FIG. 17 shows a common Swift™ frameand cushion assembly 310 in isolation, including prong elements 315 forengagement with the user's nares. FIG. 18 shows a supplemental Vista™style cushion 320 adapted for use with the Swift™ cushion/frame assembly310. The mask assembly is supported on the user's head using a headgearassembly as described above.

The supplemental cushion 320 includes at least one hole 325 provided onits lateral side for insertion over the frame/cushion assembly 310.Supplemental cushion 320 also includes a centrally located hole 330 thataligns with the gas washout vents 335 of the frame/cushion assembly 310.FIG. 19 shows the frame/cushion assembly 310 and the supplementalcushion 320 in assembled form. To assemble the supplemental cushion overthe frame, each hole 325 of the supplemental cushion 320 is stretchedover the connector of the frame, and the resiliency of the material ofthe supplemental cushion allows it to engage with the channels of theframe and/or to simply seal with an exposed surface of the frame cushionassembly. In this position, the prongs 315 seal with the nares, whilethe supplemental cushion includes a face contacting portion that sealswith the user' face.

6.0 Additional Embodiments

As can be determined from the description above in relation to theembodiments of FIGS. 2-13 and the embodiment of FIGS. 15-16, one aspectof the invention is directed to the combination of a Swift™ frame with aVista™ cushion component. As can be appreciated, the combination ofthese dissimilar mask systems required a number of adjustments, as canbe derived from the above description and the drawings.

6.1 Locked Elbow

Furthermore, there are additional factors that may be considered whencombining the various mask systems. For example, the force due to airpressure against the cushion may cause moments about the elbow. If thesemoments are not counteracted, the result may be the cushion rotating andlosing seal. The elbow should be stiff enough to prevent rotation underpressure. A locking or ratcheting mechanism may be implemented to lockthe rotation on the elbow when the desired angle is found. Locking maybe achieved using an interference fit, and/or locking components, suchas detents or a pin/groove arrangement. Generally, an approximation ofthe desired effect can be achieved by simply fixing the elbow in placerelative to the frame. Otherwise, simply inhibiting rotation, e.g., bystrapping the elbow to the adjacent headgear, can be effective as well.

6.2 Stiffening Member for Cushion Component

When the cushion is under pressure, moments about the cushion to frameinterface are created. The force vector points which cause the momentsmay be shifted by introducing a non-flexible or stiffening member to thecushion. That is to say, in addition to having a moment about the elbow,there is also a moment about the interface of the stiff section of thecushion and the flexible part of the cushion.

6.2.1 Stiffening Ribs

The mask assembly 340 in FIG. 20 includes a cushion component 345 thatis similar in general shape to the Vista™ cushion in terms of itsintended sealing footprint relative to the user's face, but it includesa plurality of ribs 350 that extend from the clip element 355 to the topof the cushion, to stop or help prevent the cushion from flexing aboutthe elbow (or flopping off the face). The stiffening member (ribs inthis example) will move this vector away from the elbow, and prevent thecushion from flopping off the face. The stiffening member should extendas close to the skin as possible without compromising comfort. Thecommon frame is similar to that described above and may be, e.g., aSwift™ frame.

The mask assembly 360 in FIG. 21 includes a rib 365 along the perimeterof the cushion to help support and/or push the cushion onto the user'sface. The rib 365 may be comolded with the cushion. The cushion forms abreathing cavity which receives the nose of the user, and the upper apexof the cushion extends across the bridge of the user, between the eyes.In this example, the cushion can be ResMed's Mirage™ cushion, adaptedfor assembly to common frame. Common frame is similar to that describedabove and may be, e.g., a Swift™ frame. However, the clip element 370 ofthe cushion assembly is slightly rotated such that it is positioned toface downwardly.

6.2.2 Thickened Cushion Portion

The stiffening member may take the form of one or more thickenedelements, e.g., by thickening the cushion which will result in it beingstiffer in sections. See, e.g., the relatively thickened portion ofcushion component in FIG. 13. Ribs could be made in the cushions,extending from the frame to the highest point of the cushion. A pseudoframe could be implemented where a large portion of the cushion is thicksilicone, only the areas in contact, or requiring flex (as in a “bubble”cushion or single walled membrane) will be thin.

6.3 Nose Tip Cushion Component

FIG. 22 shows a mask assembly 380 according to another embodiment of theinvention having a headgear assembly 385 and a common Swift™ frame 390as described above, as well as cushion component 395 in the form of anose tip cushion. The cushion includes a membrane that extends up theside of the nose. The membrane could extend just over the tip of thenose. The cushion could incorporate a bubble style seal over the tip ofthe nose. The mask assembly includes one or more vent openings 400provided in the frame/cushion component.

6.4 Full-Face Cushion

FIG. 23 shows a mask assembly 405 according to yet another embodiment ofthe present invention having a headgear assembly 410 and common Swift™frame 415 as described above, as well as a cushion component 420 in theform of a full-face cushion, such as that available from ResMed underthe name UltraMirage™ full-face cushion and described in U.S. Pat. No.6,513,526, incorporated herein by reference in its entirety. The cushioncomponent 420 would be adapted for use with a Swift™ type frame, asdescribed above.

The cushion 420 may include a rib 425 that extends from the bottom tothe top of the cushion. Furthermore, the frame 415 is positioned on theupper ½ to upper ⅓ of the cushion to support the cushion. The frame tocushion interface is positioned below the nose, although it may be abovethe nose. The cushion may include one or more gas washout vents 430.

7.0 Adjustable Positioning of the Cushion

7.1 Adjustable Nose Height

FIG. 24 shows a mask assembly 440 according to yet another embodiment ofthe present invention including a common Swift™ frame 445, a headgearassembly 450, and a Vista™-like cushion 455 supported by the frame.

The upper part 460 of the cushion may include a thin membrane (the lowercushion may be like a double wall Vista™ cushion). This has theadvantage of reduced weight and subjectively feels light to wear. It mayalso allow deflection around contours of nose as it will be moreflexible than a conventional thick cushion. This will help with fit andthe range of patients suited to each size.

In an alternative, the upper part 460 of the cushion shown in FIG. 24includes a bellows type arrangement around the cushion which may beinflated to help pressure and fit, like the ResMed Activa™ mask,described in U.S. Pat. No. 4,772,760 and U.S. application Ser. No.10/655,622, filed Sep. 5, 2003, each incorporated herein by reference inits entirety. In the alternative, the cushion may include a stiffdrinking straw-like structure, e.g., plastic corrugations that maintainshape in a variety of positions. The straw-like structure would click orfold into different positions to allow more or less nose height.

The lower part of the cushion 465 may include a gusset portion, a doublegusset, or a solid silicon structure.

7.2 Adjustable Cushion Height

As described above, the position of the centroid of the cushion to frameinterface (frame clip location) may be changed, depending onapplication. The closer the headgear vectors act to the centroid of thecushion the more stable the cushion will be on the face of the patient;this can reduce the rigidity required within the cushion to maintainsupport of the membrane. The frame location in FIGS. 2-13 is closer tothe centroid as compared to the location of the centroid in FIGS. 15-16.In these embodiments, the positions of the cushions relative to the faceremain generally constant.

However, it is also possible to change the position of the cushionrelative to the face and frame, while maintaining the frame in aconstant position. The mask assembly 500 in FIGS. 25-26 includes acommon Swift™ frame 505 supported by Swift™-like headgear 510, inaddition to a Vista™ like cushion 515 supported by the frame 505.

In FIGS. 25-26, the axis of location of the frame 505 is across themiddle of the nose, although it could be higher or lower. Asschematically shown, the axis of location of the frame onto the cushionmay vary according to user preference (which will be influenced by headshape/headgear angles). In FIGS. 25-26, it can be seen that theheadgear-frame angle remains constant and the frame is located at higheror lower cushion positions, position 2 in FIG. 25 and position 3 in FIG.26. Adjustment can be effected using mechanical expedients such as asliding arrangement. Holes in the sides of the cushion may allowstretching in to accommodate positioning of the cushion in the variouspositions.

Alternatively, the headgear and frame angle may rotate around the samecushion position. As a further alternative the headgear location pointcould be on a lobe or cam to move it relative to the cushion. A furtherembodiment is the use of weight to change the center of gravity of thecushion or frame/headgear system.

8.0 Chin Strap

FIGS. 27-31 illustrate a mask assembly 600 according to a furtherembodiment of the present invention. Mask assembly includes a frame 605(e.g. polycarbonate shell), a headgear assembly 610, a cushion component615, and a chin strap assembly 620 supported by the frame.

Chin strap assembly 620 includes an extender 625 and chin strap 630.Extender 625 is shown in FIG. 30 and is preferably made of a rigidmaterial, e.g., polycarbonate or a rigid plastic backed with headgearfoam material. Extender 625 includes an aperture 635 by which a bevelclip 640 (FIG. 29) may be used to selectively attach the extender 625 tothe frame, e.g., using interference snap fit. Extender 625 includes ahole 640 for receiving a strap 645 of the chin strap. Each strapincludes hook and loop fastening elements, e.g., Velcro®.

Chin strap 630 includes a cushion sealing area 650, and is made from afoamed headgear material. The chin strap is preferably elastic. Chinstrap is bonded to the frame at a bond point or region 655, e.g., asshown in FIGS. 27, 28 and 31. Bonding may be achieved, e.g., viaadhesive, plasma or lamination methods.

Another variant is to simply use only the extender and chin strap shownin FIGS. 30 and 31, respectively, along with another mask of choice,e.g., ResMed's Nightingale mask, more fully described in PCT Patentapplication no. PCT/AU04/01832, filed Dec. 24, 2004, incorporated byreference in its entirety. A further embodiment is the use of theNightingale headgear with the chin strap assembly and the frame cushion.

A further embodiment is the combination the full-face seal as shown inFIG. 27, along with nasal prongs as shown in FIG. 19.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, barriatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

What is claimed is:
 1. A respiratory mask assembly for providingrespiratory therapy to a patient, the respiratory mask assemblycomprising: a frame including a main body and a pair of upper lateralarms, each of the pair of upper lateral arms including a respective oneof a pair of upper headgear connectors; a pair of lower headgearconnectors, each of said pair of lower headgear connectors configured toconnect to the frame, wherein the frame includes an opening having aclosed circular shape; a cushion component configured to releasablycouple with the frame, the cushion component including a body portionand a sealing portion, wherein the body portion is relatively harderthan the sealing portion, the body portion forming at least a portion ofa breathing chamber pressurizable to a therapeutic pressure, and thebody portion including a circular inlet opening structured to receive aflow of air at the therapeutic pressure for breathing by the patient,wherein: the circular inlet opening of the body portion is coaxiallyaligned with the closed circular shape of the opening of the frame alonga common longitudinal axis when the cushion component is releasablycoupled with the frame, the body portion includes an inside surfaceexposed to said therapeutic pressure in use and an outside surfaceexposed to ambient pressure, and the frame includes a wall arrangedalong the outside surface of the body portion so that the wall isoutside the breathing chamber, and the sealing portion is constructedand arranged to form a seal with a patient's nose and mouth, the sealingportion including a hole therein adapted to receive the patient's noseand mouth such that the flow of air at the therapeutic pressure isdelivered to the patient's nose and mouth; a positioning and retainingarrangement structured and arranged to releasably couple the bodyportion of the cushion component to the main body of the frame in asubstantially fixed, substantially non-adjustable position to resistadjustable movement between the body portion of the cushion componentand the main body of the frame, wherein the positioning and retainingarrangement comprises a pair of cushion retainer parts provided to thebody portion of the cushion component and a pair of frame retainer partsformed as part of the frame, wherein each of the pair of cushionretainer parts is structured and arranged to engage behind a respectiveone of the pair of frame retainer parts when the cushion component isreleasably coupled with the frame; an elbow structured to connect to arespiratory gas conduit to deliver the flow of air at the therapeuticpressure to the breathing chamber of the cushion component, wherein theelbow is configured to be coupled to the frame and to communicate withthe cushion component through the circular inlet opening of the bodyportion; and headgear to maintain the respiratory mask assembly inposition on a patient's head, the headgear including upper strapsadapted to connect to the upper headgear connectors of the frame andlower straps adapted to connect to the lower headgear connectors.
 2. Therespiratory mask assembly according to claim 1, wherein the positioningand retaining arrangement is structured and arranged to resistadjustable movement between the body portion of the cushion componentand the main body of the frame in an anterior-posterior direction whenthe body portion of the cushion component is releasably coupled with themain body of the frame.
 3. The respiratory mask assembly according toclaim 1, wherein each of said pair of lower headgear connectors isconnected to the frame.
 4. The respiratory mask assembly according toclaim 1, wherein the sealing portion of the cushion component includes agusset portion in at least a nasal bridge region of the sealing portion.5. The respiratory mask assembly according to claim 1, wherein the bodyportion, the sealing portion, and the breathing chamber of the cushioncomponent form a unit that as a whole is releasably coupled with theframe.
 6. The respiratory mask assembly according to claim 1, wherein:the circular inlet opening of the body portion is bounded by an annularflange that protrudes forwardly from the body portion, the mask assemblyfurther comprises a gas washout vent for washout of gas from thebreathing chamber to ambient atmosphere, and the body portion of thecushion component comprises polycarbonate and the sealing portion of thecushion component comprises silicone.
 7. A respiratory mask assembly forproviding respiratory therapy to a patient, the respiratory maskassembly comprising: a frame including a main body and a foreheadsupport extending from the main body, the forehead support including apair of upper headgear connectors, wherein the frame includes a loweropening having a closed circular shape and an upper opening having aclosed shape that is spaced apart and superior to the lower opening; apair of lower headgear connectors, each of said pair of lower headgearconnectors configured to connect to the frame; a cushion componentconfigured to releasably assemble with the frame, the cushion componentincluding a body portion and a sealing portion, wherein the body portionis relatively harder than the sealing portion, the body portion formingat least a portion of a breathing chamber pressurizable to a therapeuticpressure, and the body portion including a circular inlet openingstructured to receive a flow of air at the therapeutic pressure forbreathing by the patient, wherein: the circular inlet opening of thebody portion is coaxially aligned with the closed circular shape of thelower opening of the frame along a common longitudinal axis when thecushion component is releasably assembled with the frame, the bodyportion includes an inside surface exposed to said therapeutic pressurein use and an outside surface exposed to ambient pressure, and the frameincludes a wall arranged along the outside surface of the body portionso that the wall is outside the breathing chamber, the body portion ofthe cushion component includes a feature that is spaced apart andsuperior to the circular inlet opening of the cushion component, and thefeature of the cushion component is exposed through the upper opening ofthe frame when the cushion component is releasably assembled with theframe, and the sealing portion is constructed and arranged to form aseal with a patient's nose and mouth, the sealing portion including ahole therein adapted to receive the patient's nose and mouth such thatthe flow of air at the therapeutic pressure is delivered to thepatient's nose and mouth; a positioning and retaining arrangementincluding at least one retainer part structured and arranged to providesubstantially non-adjustable assembly between the body portion of thecushion component and the frame in which adjustable movement between thebody portion of the cushion component and the frame is substantiallyresisted; an elbow structured to connect to a respiratory gas conduit todeliver the flow of air at the therapeutic pressure to the breathingchamber of the cushion component, wherein the elbow is configured to becoupled to the frame and to communicate with the cushion componentthrough the circular inlet opening of the body portion; and headgear tomaintain the respiratory mask assembly in position on a patient's head,the headgear including upper straps adapted to connect to the upperheadgear connectors of the frame and lower straps adapted to connect tothe lower headgear connectors.
 8. The respiratory mask assemblyaccording to claim 7, wherein the at least one retainer part comprises afirst retainer part structured and arranged to engage behind a secondretainer part provided to the body portion of the cushion component whenthe cushion component is releasably assembled with the frame.
 9. Therespiratory mask assembly according to claim 7, wherein the positioningand retaining arrangement is structured and arranged to resistadjustable movement between the body portion of the cushion componentand the frame in an anterior-posterior direction when the cushioncomponent is releasably assembled with the frame.
 10. The respiratorymask assembly according to claim 7, wherein each of said pair of lowerheadgear connectors is connected to the frame.
 11. The respiratory maskassembly according to claim 7, wherein the sealing portion of thecushion component includes a gusset portion in at least a nasal bridgeregion of the sealing portion.
 12. The respiratory mask assemblyaccording to claim 7, wherein the feature comprises a protrusion on thebody portion of the cushion component.
 13. The respiratory mask assemblyaccording to claim 7, wherein the body portion, the sealing portion, andthe breathing chamber of the cushion component form a unit that as awhole is releasably assembled with the frame.
 14. The respiratory maskassembly according to claim 7, further comprising a gas washout vent forwashout of gas from the breathing chamber to ambient atmosphere, andwherein the body portion of the cushion component comprisespolycarbonate and the sealing portion of the cushion component comprisessilicone.
 15. A respiratory mask assembly for providing respiratorytherapy to a patient, the respiratory mask assembly comprising: a frameincluding a main body and a neck extending from the main body, whereinthe frame includes a lower opening having a closed circular shape and anupper opening having a closed shape that is spaced apart and superior tothe lower opening; a pair of lower headgear connectors, each of saidpair of lower headgear connectors configured to connect to the frame; abridge including a pair of upper headgear connectors, the bridgeconfigured to connect to the neck of the frame; a cushion componentconfigured to releasably couple with the frame, the cushion componentincluding a body portion and a sealing portion, wherein the body portionis relatively harder than the sealing portion, the body portion formingat least a portion of a breathing chamber pressurizable to a therapeuticpressure, and the body portion including a circular inlet openingstructured to receive a flow of air at the therapeutic pressure forbreathing by the patient, wherein: the circular inlet opening of thebody portion is coaxially aligned with the closed circular shape of thelower opening of the frame along a common longitudinal axis when thecushion component is releasably coupled with the frame, the body portionincludes an inside surface exposed to said therapeutic pressure in useand an outside surface exposed to ambient pressure, and the frameincludes a wall arranged along the outside surface of the body portionso that the wall is outside the breathing chamber, the body portion ofthe cushion component includes a feature that is spaced apart andsuperior to the circular inlet opening of the cushion component, and thefeature of the cushion component is exposed through the upper opening ofthe frame when the cushion component is releasably coupled with theframe, and the sealing portion is constructed and arranged to form aseal with a patient's nose and mouth, the sealing portion including ahole therein adapted to receive the patient's nose and mouth such thatthe flow of air at the therapeutic pressure is delivered to thepatient's nose and mouth; a positioning and retaining arrangementincluding at least one retainer part structured and arranged to providesubstantially non-adjustable coupling between the body portion of thecushion component and the frame in which adjustable movement between thebody portion of the cushion component and the frame is substantiallyresisted; an elbow structured to connect to a respiratory gas conduit todeliver the flow of air at the therapeutic pressure to the breathingchamber of the cushion component, wherein the elbow is configured to becoupled to the frame and to communicate with the cushion componentthrough the circular inlet opening of the body portion; and headgear tomaintain the respiratory mask assembly in position on a patient's head,the headgear including upper straps adapted to connect to the upperheadgear connectors of the bridge and lower straps adapted to connect tothe lower headgear connectors.
 16. The respiratory mask assemblyaccording to claim 15, wherein the at least one retainer part comprisesa cushion retainer part provided to the body portion of the cushioncomponent and a frame retainer part provided to the main body of theframe, wherein the cushion retainer part is structured and arranged toengage behind the frame retainer part when the cushion component isreleasably coupled with the frame.
 17. The respiratory mask assemblyaccording to claim 15, wherein the positioning and retaining arrangementis structured and arranged to resist adjustable movement between thebody portion of the cushion component and the main body of the frame inan anterior-posterior direction when the body portion of the cushioncomponent is releasably coupled with the main body of the frame.
 18. Therespiratory mask assembly according to claim 15, wherein each of saidpair of lower headgear connectors is connected to the frame.
 19. Therespiratory mask assembly according to claim 15, wherein the sealingportion of the cushion component includes a gusset portion in at least anasal bridge region of the sealing portion.
 20. The respiratory maskassembly according to claim 15, wherein the body portion, the sealingportion, and the breathing chamber of the cushion component form a unitthat as a whole is releasably coupled with the frame.
 21. Therespiratory mask assembly according to claim 15, wherein the bodyportion of the cushion component comprises polycarbonate and the sealingportion of the cushion component comprises silicone.
 22. The respiratorymask assembly according to claim 15, wherein the feature comprises aprotrusion on the body portion of the cushion component.
 23. Arespiratory mask assembly for providing respiratory therapy to apatient, the respiratory mask assembly comprising: a frame including amain body and a pair of upper lateral arms, each of the pair of upperlateral arms including a respective one of a pair of upper headgearconnectors; a pair of lower headgear connectors, each of said pair oflower headgear connectors configured to connect to the frame, whereinthe frame includes an opening having a closed circular shape; a cushioncomponent configured to releasably assemble with the frame, the cushioncomponent including a body portion and a sealing portion, wherein thebody portion is relatively harder than the sealing portion, the bodyportion forming at least a portion of a breathing chamber pressurizableto a therapeutic pressure, and the body portion including a circularinlet opening structured to receive a flow of air at the therapeuticpressure for breathing by the patient, wherein: the circular inletopening of the body portion is coaxially aligned with the closedcircular shape of the opening of the frame along a common longitudinalaxis when the cushion component is releasably assembled with the frame,the body portion includes an inside surface exposed to said therapeuticpressure in use and an outside surface exposed to ambient pressure, andthe frame includes a wall arranged along the outside surface of the bodyportion so that the wall is outside the breathing chamber, and thesealing portion is constructed and arranged to form a seal with apatient's nose and mouth, the sealing portion including a hole thereinadapted to receive the patient's nose and mouth such that the flow ofair at the therapeutic pressure is delivered to the patient's nose andmouth; a positioning and retaining arrangement including at least oneretainer part structured and arranged to provide substantiallynon-adjustable assembly between the body portion of the cushioncomponent and the frame in which adjustable movement between the bodyportion of the cushion component and the frame is substantiallyresisted; an elbow structured to connect to a respiratory gas conduit todeliver the flow of air at the therapeutic pressure to the breathingchamber of the cushion component, wherein the elbow is configured to becoupled to the frame and to communicate with the cushion componentthrough the circular inlet opening of the body portion; and headgear tomaintain the respiratory mask assembly in position on a patient's head,the headgear including upper straps adapted to connect to the upperheadgear connectors of the frame and lower straps adapted to connect tothe lower headgear connectors.
 24. The respiratory mask assemblyaccording to claim 23, wherein the positioning and retaining arrangementis structured and arranged to resist adjustable movement between thebody portion of the cushion component and the frame in ananterior-posterior direction when the cushion component is releasablyassembled with the frame.
 25. The respiratory mask assembly according toclaim 23, wherein each of said pair of lower headgear connectors isconnected to the frame.
 26. The respiratory mask assembly according toclaim 23, wherein the sealing portion of the cushion component includesa gusset portion in at least a nasal bridge region of the sealingportion.
 27. The respiratory mask assembly according to claim 23,wherein the body portion, the sealing portion, and the breathing chamberof the cushion component form a unit that as a whole is releasablyassembled with the frame.
 28. The respiratory mask assembly according toclaim 23, further comprising a gas washout vent for washout of gas fromthe breathing chamber to ambient atmosphere, and wherein the bodyportion of the cushion component comprises polycarbonate and the sealingportion of the cushion component comprises silicone.
 29. The respiratorymask assembly according to claim 23, wherein the at least one retainerpart comprises a first retainer part structured and arranged to engagebehind a second retainer part provided to the body portion of thecushion component when the cushion component is releasably assembledwith the frame.